Note: The
policies, guidelines terms and conditions stated in this announcement may
differ from those used by the NIH.

Announcement
Type

This
Funding Opportunity Announcement (FOA) is a new RFA.

Request
for Applications (RFA) Number: RFA-HS-12-006

NOTICE:
Applications submitted in response to this Funding Opportunity Announcement
(FOA) for Federal assistance must be submitted electronically through
Grants.gov(http://www.grants.gov) using the SF424 Research
and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the
application guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four (4)
weeks prior to the grant submission date. See Section IV.

Mechanism of Support. This FOA will use the AHRQ Research Demonstration and
Dissemination Projects (R18) grant mechanism.

Funds Available and
Anticipated Number of Awards. AHRQ anticipates allocating up to $2.5
million annually for three years to this FOA. AHRQ anticipates funding 25-50
awards, depending on their approved budgets. Awards issued under this FOA
depend upon the availability of funds and the submission of a sufficient number
of meritorious applications. Because the nature and scope of the proposed
research may vary from application to application, AHRQ anticipates that the
size and duration of each award may also vary. The total amount awarded and
the number of awards depends upon the numbers, quality, duration, and costs of
the applicationsreceived.

Budget and Project
Period. The total costs awarded to a grant under this FOA shall not exceed
$100,000 (including F&A costs) per year, for a project period that may be
up to three years. An application with a budget or with a project period that
exceeds either of these limits will not undergo peer review. Funding beyond
the first year will be contingent upon a review and acceptance by Agency staff
of the annual progress report (PHS 2590).

Application Research
Strategy Length: The R18 Research Strategy section may not exceed 10
pages, including tables, graphs, figures, diagrams, and charts.

Eligible Project
Directors/Principal Investigators (PDs/PIs): Individuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are always encouraged to apply for AHRQ
support.

Number of PDs/PIs: Only
one PD/PI may be designated on the application.

Number of Applications: Applicants
may submit more than one application, provided each application is scientifically
distinct.

Resubmissions: Resubmission applications
are not permitted in response to this FOA.

Renewals:Renewal applications are
not permitted in response to this FOA.

Hearing Impaired:Telecommunications
for the hearing impaired are available at: TTY 301-451-5936.

While
grant awards are made to institutions rather than individuals, this
announcement and its instructions are written to inform individual researchers
of this funding opportunity and facilitate the submission of grant applications
by their organizations.

AHRQ: AHRQ’s mission is to improve the quality, safety,
efficiency, and effectiveness of health care for all Americans. AHRQ achieves
this mission by supporting a program of health services research and by working
with partners, including patients and health care providers, to identify and
prioritize topics that will promote improvements in clinical and health systems
practice that benefit patients. To this end, the Agency supports research on
patient outcomes and effectiveness. Among other things, this research compares
the effect of different interventions on the same health condition. By
measuring actual outcomes under real world conditions, researchers develop
scientific evidence about what works best, for whom, and under what
circumstances. Patients and practitioners can then more knowledgably choose
among treatment options. Health care managers and purchasers can identify
potentially effective strategies to improve the quality and value of care.
Stakeholders and policymakers can evaluate proposed improvements using a common
nomenclature and the same underlying evidence.

PCORI: The independent Patient-Centered Outcomes Research
Institute (PCORI) supports research about the best available evidence to help
patients and their health care providers make more informed decisions (http://www.pcori.org). PCORI has the mission
of funding evidence-based research to help patients better understand the value
of prevention, treatment, and care options available; and of the science that
supports those options.

Outcomes research: This FOA supports dissemination of
existing knowledge about what health care options (including diagnoses,
treatments, interventions, health services systems, and models of health care
delivery) work best for patients, rather than generation of new knowledge.
Examples of existing research appear on AHRQ-related Websites and publications
(http://www.ahrq.gov, http://www.ahrq.gov/clinic/, http://www.effectivehealthcare.ahrq.gov/index.cfm).
The professional literature provides additional sources of patient-centered
outcome research. Applications may propose dissemination of the results of
AHRQ-related research, findings published by PCORI, and/or other government-funded
research relevant to comparative clinical effectiveness research. In the
latter case, the disseminated research should have validity, generalizability,
accuracy, reliability, precision, usability, etc. comparable or superior to
AHRQ-related results.

Associations: Health professionals associations can play
an important role in disseminating patient-centered outcomes research. Many associations
have an extended history of maintaining the skills and improving the education of
their members. In some cases, they have already created systems for continuing
their members’ education on an on-going and sustainable basis. Some also
educate patients, clients, public, or another wider audience. AHRQ has
previously had few opportunities to leverage the specific expertise of health
professionals associations. Section III.1.A further describes the institutions
eligible to apply.

Dissemination

Background: Previous distribution of health care outcomes
information to health professionals has classically taken the form of academic
papers, textbooks, periodicals, pamphlets, lectures, broadcasts, and other
traditional forums. However, research suggests that the instructional methods
(e.g., passive reading and one-way listening) have limited effect on provider behaviors
or patient-centered health outcomes. Some literature also describes modest
experimentation with group discussions (e.g., interactive grand rounds), paid
opinion leaders (e.g., academic detailing), hands on demonstrations (e.g., by
medical equipment salesmen), clinical simulations, standard patients, virtual
patients, recertification, virtual learning environments, and other
initiatives. The limited number of studies and small sample sizes make it
difficult to draw any firm conclusions about the uptake or outcomes of such
interventions. Physicians and other health care providers increasingly look to
social media to obtain the most up-to-date information about health care.

Developments: This FOA solicits applications from health professionals
associations to develop dissemination programs that integrate patient-centered
outcomes research into clinical practice using multi-factorial mechanisms such
as education, credentialing, scientific programs, social media platforms, and
other innovative methods. Applicants may wish to consider both educational theory
(what learning methods work most effectively) and the relevance of “new
media.” Experiments with computer-based training, long distance learning,
broadcasting, videos, and other technologies have had mixed results. More
recent developments such smart phones, social networking (community-based
sites, third-party anonymous sites, crowd-sourcing), Internet games, social
media, blogs, online message boards, virtual communities, podcasting, etc.
remain largely untested for their effectiveness in promoting health.
Accordingly, voluminous opportunities exist for assessment of these innovations.

Audience: Applications may find it helpful to explicitly
define their target audience; usually the constituency of the organization or a
portion of that constituency. Dissemination intended to directly change the
behavior of all health professionals might employ a different subject and
format than a program aimed at influencing a narrow allopathic subspecialty
(e.g., hard tissue plastic surgeons, oculoplasticians) or a specific allied
health profession (e.g., pediatric occupational therapists, aviation
paramedics). A program with a nonspecific audience would likely need above-average
strengths in other areas to successfully compete.

Design

Plan: Applications must detail a multistep development
plan of up to three years for a patient-centered outcomes research
dissemination infrastructure. Propose its relationship to the governance of the
health professionals’ organization or association, if applicable. Describe anticipated
milestones and itemized aims for each year of the grant budget period, if
pertinent.

People: Key personnel should include a multidisciplinary
team of junior and senior-level health services investigators with experience
in medicine, public health informatics, clinical and health sciences research,
epidemiology, statistical design, health organization design, and/or
administration, as appropriate. Some proposed interventions may require systems
engineering, behavioral economists, translational sciences, marketing, public
relations, communications, and/or medical education specialists. A
well-coordinated, well functioning team might also demonstrate experience in
patient-centered outcomes research translation and dissemination methods,
clinical care communications, marketing and media campaigns with use of social
networking, and/or knowledge and skill sets in multi-stakeholder engagement. A
proven record of collaborative partnerships, capacity and ability to scale up
quickly, and formation of partnerships within their realm of professional
associations, state, regional, and/or local communities would add credibility
to multilateral interventions.

Need: Demonstrate demand for the proposed intervention
(e.g., a survey of professional organization demographics, inquiry of
partnering stakeholders working with the professional association, poll of
internal membership needs for improving their role and function in enhancing
healthcare service delivery), if appropriate. Needs assessment may include, but
is not limited to, activities such as: focus group interviews, literature scan for
existing validated methods, and review of the grey literature for tools,
instructional techniques of patient-centered outcomes, and health services
research dissemination methods used by health professionals’ organizations.

Subject: Identify a primary PCOR issue or topic (i.e., outcomes
research on a clinical area or disease treatment, adherences, preferences, care
transition model, or systems pathway). Ideally, it should fall within one or
more of AHRQ’s priority conditions and populations. The PCOR issues should
have direct significance to one or across multiple health professionals
associations, specialties, or subspecialties. The applicant should consider
examining widely used evidence-based resources (i.e., recent systematic
reviews, meta-analyses, registry data, surveillance, surveys, etc.) that
describe the importance and burden of the issue. Absent such data sources, reviews
of case reports and surveys of the grey literature may be used to guide topic
selection. If limited to specific health provider audiences, then provide a brief
justification for a targeted dissemination of valid patient-centered outcomes
research findings (e.g., www.effectivehealthcare.ahrq.hhs.gov;
decision aid of therapies to primary care providers within a health maintenance
organization’s multicenter electronic clinic visit template; pilot use of
previously tested, patient oriented techniques to midwives, dissemination to
health professionals serving priority populations).

Scalability: Any proposed pilot project should discuss
short-term (1-3 year) scalability of the dissemination infrastructure and long
term (4+ years) milestones required to achieve any proposed extensions. Such a
pilot should address sustainability, feasibility, financing, and effectiveness
for continuation after this project. Alternately, such applicants should consider
providing a “capstone” white paper with clear recommendations for next phase in
infrastructure implementation prior to completion of the grant period.

Sustainability: An intervention that depends on
continuation past the grant period should have a credible plan for
sustainability. If the Eligible Organization commitment to future support
depends upon this intervention’s success, then [1] detail the required
conditions and [2] outline the scope of resultant financial resources, internal
infrastructure, business plan, educational systems, or other mechanisms. An
application with a self-funding mechanism (e.g., user fees, advertising,
membership dues) would likely be more sustainable than an application than an
application that proposes to solicit contributions or to apply for additional
grants to sustain future activities. The startup infrastructure might
integrate into existing systems of quality improvement, education,
certification, or other on-going mechanisms.

Evaluation: If the application proposes a larger or longer
dissemination intervention, then does it include methods for quantifying its
results? The measurement effort will vary depending upon the project’s scope.
Thus, a single-year project with a one-time, short-term intervention might omit
a specific evaluation of the intervention, particularly where an existing
government or trade association statistical series already assembles and
distributes pertinent data. A more sustained, expensive intervention might
justify an independent measurement process.

This Funding Opportunity Announcement (FOA) will use
the AHRQ Research Demonstration and Dissemination Projects Grant (R18) award mechanism. The individual researcher sponsored by each organizational applicant will
be solely responsible for planning, directing, and executing his or her
proposed projects.

AHRQ is not using the Modular Grant Application and Award
Process.Applications submitted in modular format will not be reviewed.

2. Funds Available

AHRQ intends to commit up to $2.5 million in FY 2012 to fund 25-50
awards. Applications may be up to three years in duration with a budget
supported by AHRQ not to exceed $100,000 per year total costs (including both
direct and indirect costs) to the government. Applications with project periods
that exceed three years or budgets that exceed $100,000 total costs in any
given year will not be reviewed.

Funding beyond the first year will be contingent upon a review by Agency
staff of the annual non-competing continuation progress report. An application
with a budget that exceeds $300,000 total costs over a three year project
period will not be reviewed.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of AHRQ provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications. Facilities and administrative (F&A) costs requested by
applicants are included in the total cost limitation.

AHRQ’s authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research
mechanism, thus for the purpose of this FOA, AHRQ will make grants only to
non-profit organizations. For-profit organizations may participate in
projects as members of consortia or as subcontractors only. Because the
purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or
as subcontractors only. Applications submitted by for-profit
organizations or foreign institutions will not be reviewed. Organizations
described in section 501(c) 4 of the Internal Revenue Code that engage in
lobbying are not eligible.

HHS grants policy requires that the grant recipient
perform a substantive role in the conduct of the planned project or program
activity and not merely serve as a conduit of funds to another party or
parties. If consortium/contractual activities represent a significant portion
of the overall project, the applicant must justify why the applicant
organization, rather than the party(s) performing this portion of the overall
project, should be the grantee and what substantive role the applicant
organization will play. Justification can be provided in the Specific Aims or
Research Strategy section of the PHS398 Research Plan Component sections of the
SF424 (R&R) application. There is no budget allocation guideline for
determining substantial involvement; determination of substantial involvement
is based on a review of the primary project activities for which grant support
is provided and the organization(s) that will be performing those activities.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the PD/PI is invited to work
with his/her organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for AHRQ support.

2. Cost Sharing or Matching

This program
does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes
applicant institutions, including any collaborating institutions, to devote
resources to this effort. An indication of institutional support from the
applicant and its collaborators indicates a greater potential of success and
sustainability of the project. Examples of institutional support would include:
donated equipment and space, institutional funded staff time and effort, or
other resource investments. Applicant institutions that plan to provide support
should indicateinstitutional support by outlining the specific
contributions to the project and providing assurances that their organization
and any collaborators are committed to providing these funds and resources to
the project. This can be included at the end of the budget justification
section of the application, but institutional support dollars are not to be
shown/included in the detailed budget request.

3.
Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
However, AHRQ will not accept similar grant applications with essentially the
same research focus from the same applicant organization.

Resubmissions.Applicants are
not permitted to submit a resubmission application in response to this FOA.

Renewals. Renewal applications
are not permitted in response to this FOA.

Section IV. Application and Submission Information

To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically”
button in this FOA or link to http://www.grants.gov/Apply/ and follow the
directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the
steps of the registration process could take four to six weeks. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons.
All registrations must be complete by the submission deadline for the
application to be considered “on-time” (see 3.C.1 for more information about
on-time submission).

A one-time registration is required for
institutions/organizations at both:

The individual designated as PD/PI on the application must be
registered also in the NIH eRA Commons.

The PD/PI must hold a PD/PI account in the Commons. Applicants
should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if
they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both
roles should exist under one Commons account.

The PD/PI at the applicant organization must be affiliated with
that organization. A PD/PI located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must be done by the AOR/SO or
his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in
the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process
is not sequential. Applicants should begin the registration processes for both
Grants.gov and eRA Commons as soon as their organization has obtained a DUNS
number. Only one DUNS number is required and the same DUNS number must be
referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
throughGrants.gov/Apply.

Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.

The SF424 (R&R) Application Guide is critical to
submitting a complete and accurate application to AHRQ. Some fields within the
SF424 (R&R) application components, although not marked as mandatory, are
required by AHRQ (e.g., the “Credential” log-in field of the “Research &
Related Senior/Key Person Profile” component must contain the PD/PI’s assigned
eRA Commons User ID). Agency-specific instructions for such fields are
clearly identified in the Application Guide. For additional information, see
“Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several
components. Some components are required, others are optional. The forms
package associated with this FOA in Grants.gov/APPLYincludes all
applicable components, required and optional. A completed application in
response to this FOA includes the data in the following components:

When a single institution is involved, follow the
instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions
are involved, one institution must be designated as the prime institution and
funding for the other institution(s) must be requested via a subcontract to be
administered by the prime institution. When submitting a detailed budget, the
prime institution should submit its budget using the Research & Related
Budget component. All other institutions should have their individual
budgets attached separately to the Research & Related Subaward Budget
Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application
Guide for further instruction regarding the use of the subaward budget
form.

To allow AHRQ staff to estimate the potential peer review
workload and plan the review (e.g., anticipate the nature of reviewer expertise
to be required), prospective applicants may submit a letter of intent that
includes an acknowledgement of interest in this funding opportunity (please
refer to the number and title of this funding opportunity), a few comments on
the subject of the proposed research, background expertise of key personnel,
and the nature and role of participating institutions. Please include the
name and email address of the Principal Investigator.

This letter of intent is not required, is not binding,
and is not considered in the review of a subsequent application. However,
these letters are administratively very helpful, as indicated above. To be
most useful, the letter of intent is to be sent by the date listed above and at
the beginning of this document.

The letter of intent can be sent electronically, and
should be sent to:

In order to expedite the review, applicants are requested
to notify the AHRQReferral
Office by email Gerald.Calderone@ahrq.hhs.govwhen the application has been
submitted. Please include the FOA number and title, PD/PI name, and
title of the application.

3.C. Application Processing

Applications must be received on or
before the application receipt date described above (see Section IV.3.A. for all dates). If an application is
received after that date, the application may be delayed in the review process
or not reviewed.

Submission to Grants.gov is not the last step.
Applicants must follow their application through to the eRA Commons to check
for errors and warnings and view their assembled application.

There will be an
acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons. Information on the status
of an application should be checked by the Principal Investigator in the eRA
Commons at: https://commons.era.nih.gov/commons/.

Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH, and AHRQ. Incomplete or non-responsive
applications will not be reviewed.

Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on the application status
in the Commons.

AHRQ will not accept any
application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an “Introduction” describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.

Although there is no immediate acknowledgement of the
receipt of an application, applicants are generally notified of the review and
funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services
(CMS) public-use data, if required, should be discussed in the
application narrative and included in the budget. Projects will ordinarily not
use CMS (Medicare or Medicaid) data involving individual identifiers. However,
for applications that propose to use Medicare or Medicaid data that are individually
identifiable, applicants should state explicitly in the “Research Design
and Methods” section of the Research Plan (form 398) the specific files, time
periods, and cohorts proposed for the research. The applicant should
obtain an estimate for the cost of the requested data, if possible. This
estimate will be included in the estimated total cost of the grant at the time
funding decisions are made.

Applicants
should be aware that for individually identifiable Medicare and Medicaid data,
Principal Investigators and their grantee institutions will be required to
enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality
of data in accordance with the terms of the DUA and applicable law.

In developing research plans, applicants should allow
time for refining, obtaining approval, and processing of their CMS data
requests. Requests may take six months from the time they are submitted to
complete. Applications proposing to contact beneficiaries or their providers
require the approval of the CMS Director and may require meeting(s) with CMS
staff.

CMS data are provided on IBM mainframe tapes using the
record and data formats commonly employed on these computers. Applicants should
either have the capability to process these tapes and formats or plan to make
arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the
AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not
include the cost of identifiable CMS data in the budget. In the event
the total costs of the project plus the cost of CMS data is greater than the
total cost cap of this FOA, the budget for the project will be adjusted so that
the total costs awarded to the recipient plus the CMS data costs do not exceed
the cost cap.

For efficient grant administration, AHRQ grant administration procedures
will be used and conducted in accordance with the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy
Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A
grantee may, at its own risk and without AHRQ prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs are necessary to conduct the
project and would be allowable under the grant, if awarded, without AHRQ prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain AHRQ approval before incurring the cost. AHRQ prior
approval is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.

The applicant organization
must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic Submission of Grant Applications.”

PHS398
Research Plan Component Sections

All application instructions
outlined in the SF424 (R&R) Application Guide that are not otherwise
specified within this Funding Opportunity Announcement are to be followed,
incorporating "Just-in-Time" information concepts, and with the
following additional requirements:

Introduction is limited to 1
page.

Specific Aims is limited to 1
page.

Research Strategy, including
tables, graphs, figures, diagrams, and charts is limited to 10 pages.

Budget
Component

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award
Process. Applicants for funding from AHRQ should ignore application
instructions concerning the Modular Grant Application and Award Process, and
prepare applications using instructions for the Research and Related Budget
Components of the SF 424 (R&R). Applications submitted in the Modular
format will not be reviewed.

Warning: Please
be sure that you observe the total cost, project period, and page number
limitations specified above for this FOA. Application processing may be delayed
or the application may be rejected if it does not comply with these
requirements.

Do not use the Appendix to
circumvent the page limitations of the Research Plan component. An application
that does not comply with the required page limitations may be delayed in the
review process.

Priority Populations

The Healthcare Research and Quality Act of 1999, in
amending the Public Health Service Act, directed AHRQ, in carrying out its
mission, to conduct and support research and evaluations, and to support
demonstration projects, with respect to the delivery of health care in
inner-city and rural areas (including frontier areas), and health care for
priority populations. Priority populations include low income groups; minority
groups; women; children; the elderly; and individuals with special health care
needs, including individuals with disabilities and individuals who need chronic
care or end-of-life health care. This authority is found at 42 USC
299(c). To implement this statutory mandate, AHRQ published a Notice in
the NIH Guide on February 28, 2003, establishing a new Agency policy on the
Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the
results of AHRQ-funded research into practice and policy, grantees are to
inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when
articles from their AHRQ-supported activities are accepted for publication in
the professional literature. Grantees should also discuss any ideas about
other dissemination and marketing efforts with OCKT staff. The goal is to
ensure that efforts to disseminate research findings are coordinated with other
Agency activities to maximize awareness and application of the research by
potential users, including clinicians, patients, health care systems and
purchasers and policymakers. This is critical when outreach to the
general and trade press is involved. Accordingly, contact with the media
will take place with close coordination between OCKT and the press offices of
the grantee's institutions. In cases when products are created (such as
annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to
submit to OCKT a brief plan describing how the product will be
publicized. An OCKT staff person will be assigned to each product and
will coordinate the implementation of the plan, especially issues related to
printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs,
AHRQ may request information essential to an assessment of the effectiveness of
Agency research programs. Accordingly, grant recipients are hereby
notified that they may be contacted after the completion of awards for periodic
updates on publications resulting from AHRQ grant awards, and other information
helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed
of publications, as well as the known uses and impact of their Agency-sponsored
research. Applicants must agree to notify AHRQ immediately when a manuscript
based on research supported by the grant is accepted for publication, and to
provide the expected date of publication as soon as it is known, regardless of
whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of
AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical
Expenditure Panel Survey (MEPS). HCUP is a family of health care
databases and related software tools and products developed through a
Federal-State-Industry partnership. HCUP databases bring together the
data collection efforts of State data organizations, hospital associations,
private data organizations, and the Federal government to create a national
information resource of patient-level health care data. HCUP databases
provide data beginning in 1988 and contain encounter-level information for all
payers compiled in a uniform format with privacy protections in place.
HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS)
and the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department
Sample (NEDS), and three types of State databases, the State Inpatient
Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State
Emergency Department Databases (SEDD). More information on HCUP can be
found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally
representative estimates of health care use, expenditures, sources of payment,
and insurance coverage for the U.S. civilian, non-institutionalized population.
MEPS is composed of three component surveys: the Household Component (HC), the
Medical Provider Component (MPC), and the Insurance Component
(IC). The Household Component is the core survey, and it forms the
basis for the MPC sample and part of the IC sample. The MEPS IC collects
data on health insurance plans obtained through employers and unions, including
the number and types of private insurance plans offered, employer
characteristics, premiums, and contributions by employers and employees.
More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not
preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages
applicants to write Informed Consent (IC) and HIPAA Authorization documents for
research to be understandable to all potential research participants, including
those with low levels of literacy and limited English proficiency. AHRQ
recommends that IC and Authorization documents be written in accordance with
health literacy principles, and that IC and Authorization documents be
available in multiple languages if potential research participants include
individuals with limited English proficiency. AHRQ also recommends adopting a
process to verify potential research participants’ understanding.

IC documents must
provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the
Privacy Rule, authorization documents must include core elements and required
statements in 45 CFR 164.508(c) and must be written in plain
language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk
Research (http://www.ahrq.gov/fund/informedconsent/)
provides sample forms and guidance on adapting them, and also describes an
appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products
produced under an AHRQ-funded grant should be appropriate for the target
audience. This includes individuals from diverse cultural, language, and
literacy backgrounds. Audience testing should be part of the development
process. AHRQ’s Talking Quality website (http://www.effectivehealthcare.ahrq.gov/options/start-conversation/)
and AHRQ’s guide and checklist for developers and purchasers of health
information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure
appropriateness of consumer products.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing; the format of the final dataset; the
documentation to be provided; whether or not any analytic tools also will be
provided; whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use); and the mode of data sharing (e.g., under its own auspices by
mailing a disk or posting data on its institutional or personal website or
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the application.

The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.

Section V. Application Review Information

1. Criteria

Administrative Criteria: Upon
receipt, applications will be reviewed by AHRQ for completeness and
responsiveness.

Merit Review Criteria: Merit Review Criteria, as described below, will
be considered in the review process.

2. Review and
Selection Process

Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened in accordance with standard AHRQ peer review procedures that are
described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive
applications or applications not following instructions given in this FOA will not
be reviewed.

As part of the initial merit review, all applications
will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed
and assigned a priority score

Receive a written critique

The mission of AHRQ is to improve the quality, safety, efficiency, and
effectiveness of health care for all Americans. As part of this mission,
applications submitted to AHRQ to support health services research are
evaluated for scientific and technical merit through the AHRQ peer review
system.

Overall Impact

Reviewers will provide
an overall impact/priority score to reflect their assessment of the likelihood
for the project to exert a sustained, powerful influence on the research
field(s) involved, in consideration of the following five scored review
criteria, and additional review criteria (as applicable for the project
proposed).

Scored Review
Criteria

Reviewers will consider
each of the five review criteria below in the determination of scientific and
technical merit, and give a separate score for each. An application does
not need to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance. Does this study address an important problem? If the aims of the
application are achieved, how will scientific knowledge or clinical practice be
advanced? What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?

Does the
application propose dissemination of important and valid patient-centered
outcomes research? Does the scientific literature largely endorse the
conclusions, guidelines, recommendations, or other outputs of this research?
Do significant numbers or proportions of practitioners not adhere to these
recommendations? How would the application control for variables and trends
that affect acceptance of the recommendations? Does the research foster
multi-disciplinary teamwork in clinical care? Does the research enhance
professional interaction with peers and experts in a specific field?

Investigators.Are the PD/PI and other key personnel
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level(s) of the principal
investigator(s) and other researchers? Does the PD/PI and investigative team
bring complementary and integrated expertise to the project (if applicable)?

Innovation. Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches or methodologies, tools, or technologies for this area?

Does the dissemination intervention show originality,
innovation, and vision? Does the intervention develop or employ novel
concepts, instructional techniques, approaches, methodologies, tools, or
technologies? Does it address an innovative hypothesis or critical barriers to
progress in the field?

Approach. Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well-integrated,
well-reasoned, and appropriate to the aims of the project? Does the applicant
acknowledge potential problem areas and consider alternative tactics?

Does the application propose a specific dissemination
intervention? If so, does the intervention relate to patient-centered outcomes
research? Does it have well defined, measureable inputs and outputs? Is it
feasible? Could the intervention work well in the real world? Does any
evidence exist about its likely success (e.g., from the mechanism’s use in non-health
fields)?

Environment. Do(es) the scientific environment(s) in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment(s), or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?

2.A. Additional Review Criteria

In addition to the above criteria,
the following items will be addressed and considered in the determination of
scientific merit and the rating.

Degree of Responsiveness:How well does the application address the purpose and
objectives of this FOA? How responsive is the application to the special
eligibility criteria, including the project requirements, noted in the FOA?

Budget and Period of Support: Is
the proposed budget reasonable and is the requested period of support
appropriate in relation to the proposed research?

Protection of Human Subjects
from Research Risk: The involvement of human subjects and protections
from research risk relating to their participation in the proposed research
will be assessed. See the “Human Subjects Sections” of the PHS398 Research
Plan component of the SF424 (R&R).

Selection Process

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as
determined by peer review

Availability of funds

Responsiveness to goals and objectives of the FOA

Relevance to program priorities

Portfolio and programmatic balance

2.B. Additional Review Considerations

Not Applicable.

2.C.
Resource Sharing Plan(s)

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c),
requires that information that is obtained in the course of AHRQ-supported
activities and that identifies individuals or establishments be used only for
the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported
activities and that identifies an individual may be published or released only
with the consent of the individual who supplied the information or is described
in it. There are civil monetary penalties
for violation of the confidentiality provision of the AHRQ statute. 42 - USC
299c-3(d). In the Human Subjects section of the application, applicants
must describe procedures for ensuring the confidentiality of the identifying
information to be collected. The description of the procedures should
include a discussion of who will be permitted access to this information, both
raw data and machine readable files, and how personal identifiers and other
identifying or identifiable data will be restricted and safeguarded.
Identifiable patient health information collected by grantees under this
FOA will also be obtained and managed in accordance with the HIPAA Privacy
Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the
disclosure of personally identifiable patient information by covered entities
and define when and how such information can be disclosed e.g., to
researchers. Thus, health care plans ordinarily will require either
patient authorization for disclosures of identifiable information to be made to
researchers or waivers of such authorizations obtained from an IRB or Privacy
Board (defined in the regulations), which will involve review to ensure that
identifiable health information will be appropriately safeguarded by the
investigators. The DHHS Office of Civil Rights is the enforcement body
for this regulation. Additional information about the regulations, their
implementation, and alternative methods of permissible disclosures to researchers
(limited data sets with data use agreements, de-identified data sets, data
about deceased persons, and data use to develop protocols) can be obtained
from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems
containing confidential data have a level and scope of security that equals or
exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website
in prior paragraph) and that established by the Office of Management and Budget
(OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published
several implementation guides for this circular. They are: An Introduction to
Computer Security: The NIST Handbook; Generally Accepted Principals and
Practices for Securing Information Technology Systems; and Guide for Developing
Security Plans for Information Technology Systems. The circular and guides are
available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/.
The applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be addressed
in the application.

Sharing Research Resources: Rights
in Data

Unless otherwise provided in grant awards, AHRQ grantees
may copyright, or seek patents for, as appropriate, final and interim products
and materials developed in whole or in part with AHRQ support, including, but
not limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce,
publish, use or disseminate for any purpose consistent with AHRQ’s statutory
responsibilities and to authorize others to do so for any purpose consistent
with AHRQ’s statutory responsibilities. In accordance with its legislative
dissemination mandate, AHRQ purposes may include, subject to statutory
confidentiality protections, making project materials, databases, results, and
algorithms available for verification or replication by other researchers. In
addition, subject to AHRQ budget constraints, final products may be made
available to the health care community and the public by AHRQ or its agents if
such distribution would significantly increase access to a product and thereby
produce substantial or valuable public health benefits. Ordinarily, to
accomplish distribution, AHRQ publicizes research findings but relies on
grantees to publish research results in peer-reviewed journals and to market
grant-supported products. AHRQ's Office of Communications and Knowledge
Transfer (OCKT) wishes to be consulted in advance of publication in order to
coordinate announcements of new AHRQ-supported research results with other AHRQ
dissemination activities. Important legal rights and requirements
applicable to AHRQ grantees are set out or referenced in AHRQ's grants
regulation at 42 CFR Part 67, Subpart A (available in libraries and from the
GPO's website at http://www.gpoaccess.gov/cfr/index.html), which
incorporates additional applicable provisions on Rights in Data, including 45
CFR Part 74 and 37 CFR Part 401.

After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the NIH eRA Commons.

If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NOA signed by the AHRQ grants
management officer is the authorizing document.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NOA are at the recipient’s risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section IV.5., “Funding Restrictions.”

2. Administrative and National Policy Requirements

All
AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants
regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements
of the HHS Grants Policy Statement that are applicable based on the recipient
type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, additional
Terms and Conditions will be incorporated into the award statement.

The annual progress reports must include Section 2.2.6
items A through F as described in the general PHS form 2590 instructions. For details regarding
progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.
If instructions on the AHRQ website are different from the PHS form 2590
instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative
comments on both completed activities and plans for the remainder of that year,
including any changes foreseen in the future. At a minimum, the report
will include descriptive comments on: progress to date measured against
project aims; methodological changes implemented; key preliminary findings;
significant problems and resolutions; inclusion of priority populations; and
project related publications, presentations, and dissemination
activities. AHRQ will provide the timetable for these progress reports.

Expenditure data is to be reported on the Federal Financial Report (FFR;
SF 425). AHRQ requires annual financial expenditure reports for ALL grant
programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).
AHRQ implementation of the FFR retains a financial reporting period that
coincides with the budget period of a particular project. However, the
due date for annual FFRs will be 90 days after the end of the calendar quarter
in which the budget period ends. Note that this is a change in due dates
of annual FFRs and may provide up to 60 additional days to report, depending
upon when the budget period end date falls within a calendar quarter. For
example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013
(90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, Federal Financial Report, and
Invention Statement are required when an award ends. For further details
regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts

We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may be written or by telephone,
and fall into three areas: scientific/research (program), peer review, and
financial or grants management issues.

1. Scientific/Research Contact(s):

Direct your questions about general FOA issues, including
information on the inclusion of priority populations to:

Women and members of minority groups are included in all
AHRQ-supported research projects involving human subjects, unless a clear and
compelling rationale and justification are provided that inclusion is
inappropriate, e.g., because of the lack of connection between the study and
the health of women or particular minorities.

Investigators may obtain copies from the above sources or
from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html.
AHRQ Program staff may also provide additional information concerning
these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that
applications and proposals involving human subjects research must be evaluated
in accordance with those regulations, with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html).

The Department of Health and Human Services (DHHS)
"Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 which governs the protection of individually
identifiable health information. It is administered and enforced by the
DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools that may be used to determine whether a researcher
is a staff member of a covered entity.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research
data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation or
administrative order) may be accessed through FOIA. If no Federal action is
taken having the force and effect of law in reliance upon an AHRQ-supported
research project, the underlying data are not subject to this disclosure
requirement. Furthermore, even if a Federal regulatory action is taken in
reliance on AHRQ-supported research data, disclosure of such data is limited in
accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has
provided general related guidance at http://grants.nih.gov/archive/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential
identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this
FOA in a public archive, which can provide protections for the data (e.g., as
required by confidentiality provisions of the statute applicable to
AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable
data for an indefinite period of time, they may. The application should include
a description of any archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should consider how to structure informed consent statements or
other human subject protection procedures to permit or restrict disclosures of
identifiable data, as warranted.

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2020," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the authority
of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR
Parts 74 or 92 and other referenced applicable statutes and regulations.
All awards are subject to the terms and conditions, cost principles, and
other considerations described in the HHS Grants Policy Statement. The HHS
Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the Public Health Service mission to protect and advance the physical and
mental health of the American people.